INTERNATIONAL REGULATORY LANDSCAPE FOR FOOD ADDITIVES Lynn Insall Conference on Food Additives: Safety in Use and Consumer Concerns Nairobi, 24 June 2014

50 YEARS OF PROGRESS Increase in global population Increase in global prosperity Major changes in world trade patterns Major changes in food supply chains “Global village” People on the move More travel, transport and trade

OVERVIEW OF ADDITIVES REGULATION European Union USA China Codex Alimentarius

REGULATION IN THE EUROPEAN UNION Regulation 1331/2008, adopted December 2008 Establishes a common authorisation procedure for food additives AND food enzymes and food flavourings Replaces previous framework legislation, Directive 89/107/EEC, which set out criteria for for authorisation of food additives, definitions, general criteria for use, and labelling requirements

THE EU “GLOBAL” REGULATION Regulation (EC) No. 1333/2008 Replaces the previous specific Directives on food colours, food sweeteners, and food additives other than colours and sweeteners Applicable from 20 January 2010 Previous Directives phased out from 1 June 2013 Annexes follow food categorisation system

ADDITIVES LEGISLATION IN THE USA Part of Federal Food, Drug and Cosmetic Act (FFDCA) Food Additives Amendment to FFDCA enacted 1958 Defines food additives as “safe” or “unsafe”, excluding GRAS substances Pre-market approval required Uses food category system

THE SYSTEM IN CHINA Additives controlled by National Food Safety Standard GB Lists permitted additives and specifies conditions of use Uses hierarchical food categorisation system China committed to establishing integrated Food Safety standards systems by 2015, using Codex standards as basis

CODEX GENERAL STANDARD FOR FOOD ADDITIVES (GSFA) Adopted as a Codex standard in 1995 – CODEX STAN Intended to serve as a single authoritative reference point for food additives CIAA Categorisation System used as basis of allocation of additives to foods Still a “work in progress”

WHY DO WE NEED ADDITIVES LEGISLATION? Consumer safety Prevention of food adulteration and fraud Provision of consumer information Avoidance of barriers to trade MAJOR TRADING BLOCKS HAVE ADOPTED A “HORIZONTAL” APPROACH TO REGULATING FOOD ADDITIVES

THE “HORIZONTAL” APPROACH EU Regulations and Codex GSFA rooted in need to harmonise “Vertical” commodity legislation and compositional standards not readily adaptable to control of food additives Need for consumer protection requires monitoring of intakes Horizontal approach allows for adaptation if changes in safety assessments or consumer intake

COMMON PROVISIONS Pre-market approval of additives - numbered The need for a safety assessment Safety assessments carried out by independent scientific panels – EFSA and JECFA Definitions Safety in use – allocation of the ADI Technological need Use of additive must not mislead the consumer

CLASSES OF ADDITIVES All “horizontal” systems recognise the many classes of additives – Colours, Sweeteners, Preservatives, Antioxidants, Emulsifiers, Stabilisers etc. - though in some systems they are treated differently The use of some of these classes, and of specific additives, can be controversial Some countries and consumer groups seek to restrict the use of certain additives or additive classes

FOOD CATEGORISATION SYSTEM All regulatory schemes under discussion use a form of food categorisation system Key Food Categorisation System developed in early 1990s by CIAA (now FoodDrinkEurope) Intended to assist in allocation of additives to foods, based on hierarchical system Not adopted by the European Community in first round of harmonisation Taken up by Codex Alimentarius in the GSFA

WHY IS THIS IMPORTANT? Provides transparent method for use of food additives in “horizontal” system Facilitates allocation of additives across foods in which they are needed according to ADI Facilitates enforcement of legislation Assists in protecting consumer safety by intake reviews

IS THE LEGISLATION FIT FOR PURPOSE? Consumer safety: all “horizontal” approaches recognise the need for the safety assessment of food additives. Some more up-to-date than others Trade: differences in national legislation were seen as a barrier to trade in the European Economic Community as far back as the 1960s; Codex became the reference point for technical issues in trade disputes under the WTO's sanitary and phyto-sanitary agreements

INTO THE 21ST. CENTURY CODEX first to provide on-line database ives/search.html EU followed suit, but not necessarily reliable ?sector=FAD Need to keep electronic databases updated with any changes to additive authorisations

REQUIREMENTS FOR CHANGE? There are three main requirements in change management: Money Time Goodwill

EVER CLOSER UNION? Global trade requires a common approach in order to minimise costs, disputes and misunderstandings Consumer safety must be protected Laws and standards should recognise differences in additive needs for geographical, climatic and social reasons Flexibility needed to encourage innovation

ROOM FOR IMPROVEMENT? New EU Regulations easier to follow, more adaptable than previous legislation Programme of scientific re-evaluation will be underway for some years Any new scientific evidence has to be taken into account Codex: slow to adapt and under-resourced Inconsistencies between vertical standards and GSFA need to be resolved

TRANSITION TO THE FUTURE Improved scientific co-operation Maintain focus on consumer safety with enhanced approaches to intake assessment Respect consumer choice via information Make greater use of technology, e.g. electronic communications and “virtual” meetings More goodwill

AN INTERNATIONAL APPROACH Major trading blocks already have similar approaches to horizontal additives legislation Mutual recognition should apply where safety standards are deemed equivalent Codex GSFA should maintain its role in dispute resolution under WTO rules Codex partners should work together to resolve remaining inconsistencies and and keep GSFA up-to-date

FURTHER INFORMATION Essential Guide to Food Additives (4 th. Edition) Edited by Mike Saltmarsh RSC Publishing 2013 THANK YOU FOR YOUR ATTENTION Lynn Insall Milestone Consultancy Services